I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records. This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.

Firstly, and going back to basics, I always look at what GMP actually states about CVs and having copies in Training Records. Well the current EU GMP Chapter 2 on “Personnel” says nothing about CVs at all. Neither does USA GMP (21 CFR 211). The nearest you can get to finding anything is that 21 CFR 211 has a requirement (211.34) to have records of consultants used – but these are, of course, not employees and therefore this does not help here.

I have seen a number of organisations where they have simply asked employees to add their CV to their training records. This has causes a number of difficulties in full implementation, which on the grand scheme of things is not the end of the world, but I thought I would share them with you.

Not everyone has got an up-to-date CV

Let’s face it – you only ever update your CV when you are looking for a new job, especially with a new organisation. If you have been happily working for your current firm for over 20 years then you may not have a current CV and have no interest in writing one.

CVs have confidential information on

A normal CV will contain all of your work experience, but will often detail your home address, phone number, marital status, number of children and even hobbies. These may be important factors when applying for a new job, but are of little relevance to GMP. Because such information is often deemed as “confidential” then it is wrong to put this information in a Training Record, which is an auditable/ inspected quality record for all to see.

Training records don’t give the full story

With Training Records you normally record the training that has occurred whilst employed by the organisation. They don’t capture the training and experiences a person had before they started to work for the organisation, so there clearly is an advantage of having some form of CV that gives a broader coverage of what education, experience and jobs/ responsibilities a person has had.

The CVs are held in the Human Resources (HR) office

Because CVs often do have some degree of confidential information then they may be held in individual’s private records in the HR department. I recently actually looked at some of these when visiting a firm only to find that the CVs that they had on file were the actual ones sent in when the person applied for the job. These were also used at the interview and were covered in highlighter pens, correction fluid, scribbled questions to ask and even areas of potential strengths and weakness. They were certainly records that you would not want to show a Regulatory Inspector!

The solution

I think that there is a way to have CVs that are open, auditable, non-confidential and can comfortably be kept in public Training Records. These should be the same as a conventional CV (used when applying for a job) but with all of the private information removed. In other words they just state the education and experience of an individual and do not include their home address, the fact that they have 3 adorable children, that they have been happily married to Catherine for over 15 years and love stamp collecting!

However – do remember to keep these up-to-date, so they should capture job roles and promotions whilst at the current organisation, so you can see what experience people have had whilst within the employ of a firm.

I hope that this is helpful. Feel free to comment on what you do at your organisation with CVs. Incidentally, curriculum vitae is a Latin expression which can be loosely translated as (the) course of (my) life. Also – the plural of Curriculum Vitae is actually Curricula Vitae and not Curriculum Vitaes – but it just doesn’t look right!

8 Comments

As Dominic has stated there is no GMP requirement for CVs to be retained. There is an expectation, for “key” positions, that the poition holder has suitable experience. Dominics proposed solution of a work specific CV without any personnal data is one that my company uses. Essentially I have two CVs. One that I would use for job applications. HR hold an outdated version of this from my original application, but not my current up to date one. The second is a career specific CV which I update annually and is kept with my training record.

In essence a person’s training record should contain a summary of their relevant work experience whether this be in the form of a CV, resume or any other format.

From LinkedIn:
It’s been my experience, particularly in dealing with MHRA, that inclusion of a CV or resume in training files is expected – it is the foundation for determining if an individual is fundamentally qualified to perform their job. FDA has not specifically made a similar request during the inspections I’ve hosted.
By Christina Clothier

Well described, Dominic. Almost everywhere I audit, the cv, if it exists at all, is the one that was submitted as part of the job application. Apart from being out of date and containing personal data, it also is an advert – telling me how wonderful and indispensable this person is. The cv I give to my clients is stripped down to companies I’ve worked for/with, job title and key responsibilities. This is then easy to update annually, together with CPD records.

The FDA gave the green light to 35 new drug compounds during fiscal year 2012 (October 1, 2011-September 30, 2012). The most innovative drugs include those approved to treat cancer, cystic fibrosis, HIV, macular degeneration, Alzheimer’s disease, blood disorders meningitis and Gaucher disease, according to the FDA.

I have worked for for several Pharmaceutical and Medical Device companies and only one asked for the CV to be kept on file.
My current employer has an online system that asks for previous work history etc to be uploaded and stored in this manner against your training records that are of course constantly updating as and when new material / skills have been taught.